Delivery of controlled doses of medicaments is desirable to avoid overmedication. Overmedication can especially occur when the medicament is in the form of a creme or liquid. For example, while it is highly desirable to carefully control the dosage of medicaments given to infants or children, it can be difficult to measure the proper dose using traditional measuring devices such as measuring cups. When the medicament is in the form of a creme or ointment, such as for example cremes applied to the face to control skin acne, the medicaments are often stored in tubes or other containers that do not provide delivery of precise doses of the medicament. Application of excess amounts of the creme can result in skin irritation and drying. Also, application of cremes using fingers can result in contamination of the medicament.
For some medicaments, such as for example the antiseptic Betadyne™, delivery of a controlled dose in a precise location on the skin is desirable to avoid excessive staining of skin or clothing. For certain vaccines, such as the vaccine for gastroenteritis, a hermetically sealed dispenser that can deliver multiple precise doses of the vaccine can reduce waste of both the vaccine and dispensers.
Several devices have been described previously which permit controlled doses of medicaments to be delivered. These devices can be complicated to manufacture, assemble and fill with the medicament. As a result, these devices can be expensive to manufacture and may not be useful for over the counter (“OTC”) medicaments. Another disadvantage of such devices is that air can enter the device during storage or as the medicament is delivered. Air entering the device during storage or delivery of the medicament can cause degradation of the medicament, reducing the efficacy of the medicament or causing spoilage which may require that the medicament be discarded.
For some medicaments, preservatives are added to prevent degradation or spoilage of the medicament before use due to ingress of air or other contaminants. The preservatives can react with the medicament, however, reducing its efficacy. Also, some users can have undesirable adverse reactions to the preservatives in the medicaments.
One-way spray tips for dispensing medicaments in aerosol form or for delivery to the eye have been described in U.S. Pat. No. 5,320,845 to Dr. Daniel Py issued on Jun. 14, 1994, U.S. Pat. No. 5,613,957 to Dr. Daniel Py issued on Mar. 25, 1997, U.S. Pat. No. 5,746,728 to Dr. Daniel Py issued on May 5, 1998, U.S. Pat. No. 5,855,322 to Dr. Daniel Py issued on Jan. 5, 1999 and U.S. Pat. No. 6,053,433 to Dr. Daniel Py issued on Apr. 25, 2000, each of which is hereby incorporated by reference as part of the present disclosure.
Cosmetics, such as cremes or liquid make-ups, can also degrade or spoil with exposure to air. Accordingly, it would be desirable to provide a dispenser that could prevent the ingress of air or other contaminants into the medicament, cosmetic or other substance contained within the dispenser, as well as provide improved control of the amount of the substance dispensed therefrom. It also would be desirable to provide a hermetically sealed dispenser that could be used to deliver controlled amounts of other air-sensitive substances, such as for example glues, while preserving unused portions of the substance for later use.
Accordingly, it is an object of the present invention to overcome one or more of the drawbacks and/or disadvantages of the prior art.
The present is directed to a method for aseptically storing and dispensing a sterile food product. The method comprises the step of maintaining a sterile food product hermetically sealed within a variable-volume storage chamber of a dispenser, which includes a one-way valve coupled in fluid communication with the variable-volume storage chamber. The one-way valve includes an elastic valve member that forms a normally closed valve opening. The method further comprises the step of dispensing a plurality of different portions of the sterile food product at different points in time from the variable-volume storage chamber and through the one-way valve by pressurizing the sterile food. The food is pressurized at an inlet to the normally closed valve opening, which, in turn, moves the elastic valve member between a normally closed position and an open position. At least a segment of the valve member is spaced away from the closed position to connect the valve opening in fluid communication with the variable-volume storage chamber, to thereby allow the passage of sterile food product from the variable-volume storage chamber through the valve opening. The method further comprises the step of maintaining the sterile food product within the variable-volume storage chamber sterile and hermetically sealed with respect to ambient atmosphere throughout the above-mentioned steps.
In some embodiments, the method further comprises the steps of sterile filling the variable-volume storage chamber with the food product, and hermetically sealing the sterile food product within the variable-volume storage chamber. In some embodiment, the method further comprising the step of substantially preventing the ingress of air or other contaminants through the one-way valve and into the variable-volume storage chamber during the sterile filling and hermetically sealing steps. In some embodiments, the method further comprises the step of sterilizing the food product prior to the step of sterile filling the variable-volume storage chamber with the food product.
In some embodiments, the dispenser include a penetrable and thermally resealable portion in fluid communication with the variable-volume storage chamber, and the method further comprises the steps of sterilizing an exposed surface of the penetrable and resealable portion; penetrating the penetrable and thermally resealable portion with a filling member coupled in fluid communication with a source of the sterile food product; and introducing the sterile food product through the filling member and into the variable-volume storage chamber. Additionally, the method comprises the steps of withdrawing the filling member from the penetrable and thermally resealable portion; and applying sufficient thermal energy to the penetrated region of the penetrable and thermally resealable portion to fuse the penetrated region and form a substantially gas-tight seal between the penetrated region and the variable-volume storage chamber.
In another aspect, the invention is directed to a dispenser for storing and dispensing a sterile food product. The dispenser comprises a variable-volume storage chamber, and a one-way valve coupled in fluid communication with the variable-volume storage chamber. The valve includes an elastic valve member that forms a normally closed, axially-extending valve opening. The valve member is movable between a normally closed position and an open position with at least a segment of the valve member spaced away from the closed position to connect the valve opening in fluid communication with the variable-volume storage chamber, and thereby allow the passage of the sterile food product through the valve opening. The variable-volume storage chamber is sterile filled with the food product and the sterile food product is hermetically sealed in the variable-volume storage chamber. The dispenser maintains the food product within the variable-volume storage chamber sterile and hermetically sealed with respect to the ambient atmosphere throughout dispensing of a plurality of different portions of the food product from the storage chamber through the one-way valve.
In some embodiments the dispenser further comprises a device that exerts pressure on the food product contained within a chamber of the dispenser to dispense a plurality of different portions of the food product from the variable-volume storage chamber and through the one-way valve. In some embodiments, the dispenser further comprises a mechanism coupled to the device to move the device, exert pressure on the food product, and dispense a portion of the food product through the one-way valve.
In another aspect, the invention is directed to a dispenser for storing sterile food and dispensing multiple portions of the sterile food therefrom. The dispenser comprises a hermetically sealed, variable-volume storage chamber containing therein multiple portions of the sterile food hermetically sealed with respect to ambient atmosphere. Additionally, the dispenser comprises a one-way valve comprising a valve member formed of an elastic material forming a normally closed valve opening and an inlet to the valve opening in fluid communication with the variable-volume storage chamber. The valve member is movable radially in response to food at the inlet to the valve opening exceeding a valve opening pressure between a normally closed position and an open position. In the open position, at least a segment of the valve member is spaced radially away from the closed position to connect the valve opening in fluid communication with the variable-volume storage chamber, thereby allowing sterile food to be dispensed through the valve opening. Further, the dispenser comprises a device in fluid communication with the variable-volume storage chamber and one-way valve. The device is configured to exert pressure on food at the inlet of the valve opening to exceed the valve opening pressure and dispense a portion of the sterile food through the one-way valve. During dispensing of sterile food through the one-way valve, the one-way valve and storage chamber maintain food remaining in the storage chamber sterile and sealed with respect to ambient atmosphere. In some embodiments, the dispenser further comprises a manually-engageable mechanism coupled to the device to move the device, exert pressure on the food, and dispense a portion of the food through the one-way valve.
In another aspect, the invention is directed to a dispenser for storing and dispensing multiple portions of a sterile food. The dispenser comprises a variable-volume storage chamber including a plurality of portions of sterile food hermetically sealed therein. Additionally, the dispenser comprises means coupled in fluid communication with the variable-volume storage chamber for forming a normally closed opening, for moving between a normally closed position, and an open position. In the open position, at least a segment of said means is spaced away from the closed position to connect the opening in fluid communication with the variable-volume storage chamber and thereby allow the passage of sterile food through the opening and maintain the food within the variable-volume storage chamber sterile and hermetically sealed with respect to ambient atmosphere. The food is kept sterile and hermetically sealed throughout the dispensing of a plurality of different portions of the sterile food from the storage chamber. The dispenser further includes a device in fluid communication with the variable-volume storage chamber and said means, which is configured to exert pressure on sterile food at the opening and dispense a portion of the sterile food through said means.
In some embodiments, said means is a one-way valve. The valve comprises a valve member formed of an elastic material and forming a normally closed valve opening and an inlet to the valve opening in fluid communication with the variable-volume storage chamber, wherein the valve member is movable radially in response to food at the inlet to the valve opening exceeding a valve opening pressure between a normally closed position and an open position. In the open position, at least a segment of the valve member is spaced radially away from the closed position to connect the valve opening in fluid communication with the variable-volume storage chamber and thereby allow sterile food to be dispensed through the valve opening.